BurnsNCT07614971
Validity and Reliability of Arabic Version of Michigan Hand Questionnaire in Assessment of Hand Function Post-burn
An observational study of Burns, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study will to test the: Face validity of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn. Content validity of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Burns
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- May 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study will include hundred Egyptian patients suffering from second degree thermal burn involving the dorsal surface of the dominant hand with total body surface area (TBSA) for burns ranged from 20% to 30%. They will be selected randomly from Assuit University Hospital and Otiefy Hospital, Assuit, Egypt.
Who may be able to join
- Both genders are participated in this study.
- All patients suffering from second degree thermal burn injury involving the dorsal surface of the dominant hand with TBSA ranged from 20% to30%.
- All patients will be asked to fill the questionnaire after 1 month from burn injury and they will be asked to refill the questionnaire after 1 week.
- All participants can read and write in Arabic.
- All participants can understand items of the questionnaire easily.
- All patients enrolled to the study had their informed consent
Who cannot join
- Patients with cognitive and psychiatric disorders.
- Patients with palmar and circumferential hand burn.
- Patients with communication, vision and hearing disorders.
- Patient who don't fill the questionnaire till the end.
- Patient who aren't cooperative in filling the questionnaire.
- Suicidal burn.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validity and Reliability of Arabic Version of Michigan Hand Outcomes Questionnaire in Assessment of Hand Function Post-burn
The purpose of the study will to test the:
- Face validity of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.
- Content validity of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.
- Concurrent validity of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.
- Feasibility of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.
- Internal consistency reliability of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.
- Test- retest reliability of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.
Read the detailed description
Hand burns have a significant impact on the long-term function of burn patients. Recently, new protocols and technologies have been introduced for the treatment of hand burns. Hand burns can cause severe functional impairments since hand function is necessary to carry out daily activities and requires, but is not limited to, fine and gross dexterity, manipulating objects and various performance skills. Hand burns have also been associated with delayed return to work, which increases costs for the employer and decreases the chances for the employee to successfully return to work. hand function has a direct impact on the quality of life of burn survivors and is described as a strong predictive factor for reintegrating into society and the work setting (Corrales-Benitez et al., 2022).
Michigan Hand Outcomes Questionnaire is a domain-specific questionnaire that was developed to be used as a standardized instrument capable of measuring outcomes for patients with all types of hand disorders. It was developed to measure health state domains that are important to patients with hand disorders. The instrument can be used to evaluate a patient before hand surgery and to monitor function after the surgery. The Michigan Hand Outcomes Questionnaire has been developed under rigorous psychometric principles as a multi-dimensional measure of the health status of patients with all types of hand and wrist impairments. This questionnaire assesses the right and left hand separately to avoid the dominance effect, differentiates between functional status and symptoms, and provides two unique scales such as aesthetics and satisfaction (Martínez et al.,2024; Oksuz t al., 2011).
So, this study will be designed to provide a guideline about the usefulness of Michigan Hand Outcomes Questionnaire for assessment of hand function post burn, through assessing the validity and reliability of the questionnaire's Arabic version post burn to assist in planning an ideal treatment regimen for hand function rehabilitation post burn.
- Conditions
- Burns
- Keywords
- Burn, Hand function, Michigan Hand Outcomes Questionnaire, Validity, Reliability
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| Post-burn patient | This study will be conducted on one hundred patients, aged from (20-35) years who suffered from second degree thermal burn injury with total body surface area (TBSA) for burn ranged from (20 -30%) with the burn injury involving the dorsal surface of the dominant hand. They will participate in the current study 1 month after burn injury. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Face validity of Arabic version of Michigan Hand Questionnaire
Ten experts test the scale for clarity of instruction, items and response format (face validity) and to provide suggestions to improve its clarity using dichotomous question (clear -unclear).
Measured: 6 months
Content validity of Arabic version of Michigan Hand Questionnaire
The extent to which a research instrument accurately measures all aspects of a construct.
Measured: 6 months
Concurrent validity of Arabic version of Michigan Hand Questionnaire
It s the degree to which the results or scores on a test are related to the scores on another, already established, test administered at the same time, or to some other valid criterion available at the same time.
Measured: 6 months
Feasibility of Arabic version of Michigan Hand Questionnaire
The medical committee agreed to judge feasibility using two factors (time and missing items) regarding translated instruments. the percent of missing items shouldn't be higher than 20 %.
Measured: 6 months
Internal consistency reliability of Arabic version of Michigan Hand Questionnaire
The items within the scale reflect or measure the same concept. This means that the items within the scale correlate or are complementary to each other, assessed by using Cronbach's alpha.
Measured: 6 months
Test-Retest Reliability of Arabic version of Michigan Hand Questionnaire
The reliability coefficient obtained by repetition of the same measure on a second time is called the test-retest reliability. When a questionnaire containing some items that are supposed to measure a concept is administered to a set of respondents now, and after some time ranging from few days to weeks or months, again administered on the same respondents. The correlation coefficient calculated between two set of data and if it is found to be high, better the test-retest reliability.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startMay 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sawsan Monazea Abd Elfatah Ahmed, Cairo University
- Investigators
- Ayman Ahmed, Professor, Study director, Cairo UniversityNesreen Abdel-Rashed, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614971
- Sponsor's protocol ID
- P.T.REC/012/003621
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Corrales-Benitez C, Gonzalez-Peinado D, Gonzalez-Miranda A, Martinez-Mendez JR. Evaluation of burned hand function after enzymatic debridement. J Plast Reconstr Aesthet Surg. 2022 Mar;75(3):1048-1056. doi: 10.1016/j.bjps.2021.09.074. Epub 2021 Oct 22.
PubMed 34848129Martinez-Fernandez MV, Sarabia-Cobo CM, Sanchez-Labraca N. Cross-cultural adaptation, reliability, validity and responsiveness of the Michigan Hand Outcomes Questionnaire (MHQ-Sp) in Spain. J Orthop Surg Res. 2024 Apr 22;19(1):256. doi: 10.1186/s13018-024-04723-x.
PubMed 38649996Oksuz C, Akel BS, Oskay D, Leblebicioglu G, Hayran KM. Cross-cultural adaptation, validation, and reliability process of the Michigan Hand Outcomes Questionnaire in a Turkish population. J Hand Surg Am. 2011 Mar;36(3):486-92. doi: 10.1016/j.jhsa.2010.11.016. Epub 2011 Feb 4.
PubMed 21295925
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Arabic Version of Michigan Hand Outcomes Questionnaire in Assessment of Hand Function Post-burn
- ClinicalTrials.gov ID
- NCT07614971
- Acronym / sponsor ID
- P.T.REC/012/003621
- Conditions
- Burns
- Keywords
- Burn, Hand function, Michigan Hand Outcomes Questionnaire, Validity, Reliability
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study will to test the:
- Face validity of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.
- Content validity of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.
- Concurrent validity of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.
- Feasibility of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.
- Internal consistency reliability of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.
- Test- retest reliability of Arabic version of Michigan Hand Outcomes Questionnaire in assessment of hand function post burn.
Detailed description
Hand burns have a significant impact on the long-term function of burn patients. Recently, new protocols and technologies have been introduced for the treatment of hand burns. Hand burns can cause severe functional impairments since hand function is necessary to carry out daily activities and requires, but is not limited to, fine and gross dexterity, manipulating objects and various performance skills. Hand burns have also been associated with delayed return to work, which increases costs for the employer and decreases the chances for the employee to successfully return to work. hand function has a direct impact on the quality of life of burn survivors and is described as a strong predictive factor for reintegrating into society and the work setting (Corrales-Benitez et al., 2022).
Michigan Hand Outcomes Questionnaire is a domain-specific questionnaire that was developed to be used as a standardized instrument capable of measuring outcomes for patients with all types of hand disorders. It was developed to measure health state domains that are important to patients with hand disorders. The instrument can be used to evaluate a patient before hand surgery and to monitor function after the surgery. The Michigan Hand Outcomes Questionnaire has been developed under rigorous psychometric principles as a multi-dimensional measure of the health status of patients with all types of hand and wrist impairments. This questionnaire assesses the right and left hand separately to avoid the dominance effect, differentiates between functional status and symptoms, and provides two unique scales such as aesthetics and satisfaction (Martínez et al.,2024; Oksuz t al., 2011).
So, this study will be designed to provide a guideline about the usefulness of Michigan Hand Outcomes Questionnaire for assessment of hand function post burn, through assessing the validity and reliability of the questionnaire's Arabic version post burn to assist in planning an ideal treatment regimen for hand function rehabilitation post burn.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-burn patient | – | –This study will be conducted on one hundred patients, aged from (20-35) years who suffered from second degree thermal burn injury with total body surface area (TBSA) for burn ranged from (20 -30%) with the burn injury involving the dorsal surface of the dominant hand. They will participate in the current study 1 month after burn injury. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study will include hundred Egyptian patients suffering from second degree thermal burn involving the dorsal surface of the dominant hand with total body surface area (TBSA) for burns ranged from 20% to 30%. They will be selected randomly from Assuit University Hospital and Otiefy Hospital, Assuit, Egypt.
Key inclusion criteria (6 listed)
- Both genders are participated in this study.
- All patients suffering from second degree thermal burn injury involving the dorsal surface of the dominant hand with TBSA ranged from 20% to30%.
- All patients will be asked to fill the questionnaire after 1 month from burn injury and they will be asked to refill the questionnaire after 1 week.
- All participants can read and write in Arabic.
- All participants can understand items of the questionnaire easily.
Key exclusion criteria (6 listed)
- Patients with cognitive and psychiatric disorders.
- Patients with palmar and circumferential hand burn.
- Patients with communication, vision and hearing disorders.
- Patient who don't fill the questionnaire till the end.
- Patient who aren't cooperative in filling the questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | Post-burn patient |
Primary outcome
Face validity of Arabic version of Michigan Hand Questionnaire
Time frame: 6 months
Ten experts test the scale for clarity of instruction, items and response format (face validity) and to provide suggestions to improve its clarity using dichotomous question (clear -unclear).
Content validity of Arabic version of Michigan Hand Questionnaire
Time frame: 6 months
The extent to which a research instrument accurately measures all aspects of a construct.
Concurrent validity of Arabic version of Michigan Hand Questionnaire
Time frame: 6 months
It s the degree to which the results or scores on a test are related to the scores on another, already established, test administered at the same time, or to some other valid criterion available at the same time.
Feasibility of Arabic version of Michigan Hand Questionnaire
Time frame: 6 months
The medical committee agreed to judge feasibility using two factors (time and missing items) regarding translated instruments. the percent of missing items shouldn't be higher than 20 %.
Internal consistency reliability of Arabic version of Michigan Hand Questionnaire
Time frame: 6 months
The items within the scale reflect or measure the same concept. This means that the items within the scale correlate or are complementary to each other, assessed by using Cronbach's alpha.
Test-Retest Reliability of Arabic version of Michigan Hand Questionnaire
Time frame: 6 months
The reliability coefficient obtained by repetition of the same measure on a second time is called the test-retest reliability. When a questionnaire containing some items that are supposed to measure a concept is administered to a set of respondents now, and after some time ranging from few days to weeks or months, again administered on the same respondents. The correlation coefficient calculated between two set of data and if it is found to be high, better the test-retest reliability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 34848129Corrales-Benitez C, Gonzalez-Peinado D, Gonzalez-Miranda A, Martinez-Mendez JR. Evaluation of burned hand function after enzymatic debridement. J Plast Reconstr Aesthet Surg. 2022 Mar;75(3):1048-1056. doi: 10.1016/j.bjps.2021.09.074. Epub 2021 Oct 22.
- Background: PubMed 38649996Martinez-Fernandez MV, Sarabia-Cobo CM, Sanchez-Labraca N. Cross-cultural adaptation, reliability, validity and responsiveness of the Michigan Hand Outcomes Questionnaire (MHQ-Sp) in Spain. J Orthop Surg Res. 2024 Apr 22;19(1):256. doi: 10.1186/s13018-024-04723-x.
- Background: PubMed 21295925Oksuz C, Akel BS, Oskay D, Leblebicioglu G, Hayran KM. Cross-cultural adaptation, validation, and reliability process of the Michigan Hand Outcomes Questionnaire in a Turkish population. J Hand Surg Am. 2011 Mar;36(3):486-92. doi: 10.1016/j.jhsa.2010.11.016. Epub 2011 Feb 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayman Ahmed, Professor study director
Cairo University
Nesreen Abdel-Rashed study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sawsan Abdel-Fattah, Master (010041786292, s73644954@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Face validity of Arabic version of Michigan Hand Questionnaire (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07614971, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.